Container Closure Integrity Testing Services

Container closure integrity (CCI) is the ability of a container closure system (CCS) to maintain the sterility and product quality of sterile final pharmaceutical, biological, and vaccine products throughout their shelf-life.¹ The container closure integrity testing (CCIT) is a thorough analysis of the container closure system to assess whether it has sterile barrier protection against potential contaminants, including microorganisms, reactive gases, and other substances. CCIT is a key step in understanding the biosafety and suitability of containers, and both the US Pharmacopoeia and the FDA impose stringent requirements on CCIT.

The current regulatory guidelines on how to assess the limits of CCI are different between countries and regions, and there is no gold standard for CCIT methods, so CCIT must take into account the intended use (conventional manufacturing or quality control) and product design ( Primary packaging, product dosage form)². Alfa Chemistry's experts are committed to providing you with the most comprehensive testing method, providing a test solution that meets your expectations, and providing advanced equipment to test pharmaceutical CCS to meet the regulatory guidelines and ensure the safety of the product container closure system.

Alfa Chemistry's capabilities include but not limited to:

Some resources of CCIT include:

• USP <1207> Sterile Product Packaging-Integrity Evaluation

  USP <1207.1> Package Integrity and Test Method Selection
  USP <1207.2> Package Integrity Leak Test Technologies
  USP <1207.3> Package Seal Quality Test Methods

• FDA 21CFR211.94 Drug Product Containers and Closures

• European Commission EudraLex - Volume 4 - Good Manufacturing Practice (GMP) Guidelines

  Annex 1 Manufacture of Sterile Medicinal Products
  Part II Basic Requirements for Active Substances used as Starting Materials

• ICH Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological / Biological Products

Alfa Chemistry has a wide range of equipment, such as:

Alfa Chemistry's advantages:

References

• Ewan S. (2015) 'White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing.' PDA J Pharm Sci Technol. 69(3):461-5.

• Brown H. (2017) 'Container Closure Integrity Testing-Practical Aspects and Approaches in the Pharmaceutical Industry.' PDA J Pharm Sci Technol. 71(2):147-162.